Dexamethasone Dyspnea Study

NCT01670097 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 2012-0001NCI-2012-01615
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to learn if dexamethasone can help reduce shortness of breath in cancer patients. Researchers also want to learn if it can help to improve lung function and quality of life. In this study, dexamethasone will be compared to a placebo. Dexamethasone is commonly used for treatment of nausea, tiredness, and pain. It may help patients with shortness of breath. A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.

Conditions

Advanced Cancers; Hematologic Disorder; Solid Tumors

Keywords

Advanced Cancers; Hematologic Disorder; Solid Tumors; Dyspnea; Difficulty breathing; Shortness of breath; Dexamethasone; Decadron; Placebo; Sugar pill; Questionnaires; Surveys; Spirometer; Phone calls

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Completed the Dyspnea Numeric Rating Scale

  Number of participants who completed the dyspnea numeric rating scale on Day 7

  Baseline to Day 7

Secondary Outcomes (3)

• Edmonton Symptom Assessment System Dyspnea Score

  Baseline to Day 4, Day 7, Day 14

• Dyspnea Numeric Rating Score (Now)

  Baseline to day 4, Day 7 and Day 14

• European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core- 30 Dyspnea

  Baseline to day 4, Day 7 and Day 14.

Study Arms (2)

Dexamethasone

EXPERIMENTAL

Dexamethasone 8 mg (2 capsules of 4 mg) given orally twice a day for 4 days, then 4 mg given orally twice a day for 3 days. In the open label phase, patients assigned to either arm asked to take Dexamethasone 4 mg orally twice a day for 7 days. Patient to blow into spirometry machine 1 time a day to test lung function. Questionnaires completed at baseline and at day 7 and 14. It should take about 15 minutes to complete these questionnaires. Questionnaires completed at baseline and at day 7 and 14. It should take about 15 minutes to complete these questionnaires. Participants randomized to either dexamethasone or placebo for 7 days in a blinded fashion; this will be followed by an open label phase in which patients in both arms would take dexamethasone for 7 days.

Drug: Dexamethasone; Behavioral: Questionnaires; Device: Spirometer; Other: Phone Calls

Placebo

PLACEBO COMPARATOR

Two placebo capsules taken twice a day for 4 days, followed by one capsule twice a day for 3 days. Patient to blow into spirometry machine 1 time a day to test lung function. Questionnaires completed at baseline and at day 7 and 14. It should take about 15 minutes to complete these questionnaires. Questionnaires completed at baseline and at day 7 and 14. It should take about 15 minutes to complete these questionnaires. Participants randomized to either dexamethasone or placebo for 7 days in a blinded fashion; this will be followed by an open label phase in which patients in both arms would take dexamethasone for 7 days.

Drug: Dexamethasone; Drug: Placebo; Behavioral: Questionnaires; Device: Spirometer; Other: Phone Calls

Interventions

Dexamethasone DRUG

Group 1 Blinded Phase: 8 mg (2 capsules of 4 mg) given orally twice a day for 4 days, then 4 mg given orally twice a day for 3 days. Open Label Phase Groups 1 and 2: 4 mg by mouth twice a day for 7 days.

Also known as: Decadron

Dexamethasone; Placebo

Placebo DRUG

Group 2 Blinded Phase: Two capsules by mouth twice a day for 4 days, followed by one capsule twice a day for 3 days.

Also known as: Sugar pill

Placebo

Questionnaires BEHAVIORAL

Questionnaires completed at baseline and at day 7 and 14. It should take about 15 minutes to complete these questionnaires.

Also known as: Surveys

Dexamethasone; Placebo

Spirometer DEVICE

Patient to blow into spirometry machine 1 time a day to test lung function.

Dexamethasone; Placebo

Phone Calls OTHER

Patient called by phone 1 time each day to ask about level of shortness of breath and to remind patient to take capsules. These calls should last about 5 minutes.

Dexamethasone; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of cancer
• Dyspnea with an average intensity level \>3/10 on the numeric rating scale over the past week
• Clinical or radiologic history of lung/pleural involvement (primary or metastatic), lymphangitic carcinomatosis or airway involvement secondary to tumor infiltration
• Outpatients at MD Anderson Cancer Center seen by the Supportive Care, Rehabilitation Service, Thoracic Oncology or Pulmonary Medicine
• Able to communicate in English
• Karnofsky performance status \>=40%
• Age 18 or older
• Permission from the attending medical oncologist if the patient is currently on an interventional cancer therapy trial.

You may not qualify if:

• Delirium (i.e. Memorial delirium rating scale \>13)
• Oxygen saturation \<90% despite supplemental oxygen \>6L/min
• Previous allergic reactions to dexamethasone
• Uncontrolled hyperglycemia as defined by any blood glucose of \>300 mg/dl in the past two weeks
• Severe anemia (Hb \<7g/L) not corrected prior to study enrollment (bloodwork is not required if patient did not have recent chemotherapy within last 2 weeks)
• Post-surgical open wound that has not been healed at the time of enrollment
• Any infection requiring parenteral antibiotics within the past 2 weeks
• Major surgery within the past 2 weeks
• Megestrol use at the time of study enrollment
• Neutropenia (absolute neutrophil count \< 1.0) (bloodwork is not required if patient did not have recent chemotherapy within last 2 weeks)
• Currently on or expected to start cytotoxic chemotherapy with in 1 week of study enrollment
• Chronic obstructive pulmonary disease (COPD) exacerbation at the time of study enrollment
• Heart failure exacerbation at the time of study enrollment
• Chronic systemic corticosteroid use (\>14 days) at the time of study enrollment
• Unwilling to provide informed consent

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Hui D, Kilgore K, Frisbee-Hume S, Park M, Tsao A, Delgado Guay M, Lu C, William W Jr, Pisters K, Eapen G, Fossella F, Amin S, Bruera E. Dexamethasone for Dyspnea in Cancer Patients: A Pilot Double-Blind, Randomized, Controlled Trial. J Pain Symptom Manage. 2016 Jul;52(1):8-16.e1. doi: 10.1016/j.jpainsymman.2015.10.023. Epub 2016 Jun 18.

  PMID: 27330023 DERIVED

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Hematologic Diseases; Dyspnea

Interventions

Dexamethasone; Calcium Dobesilate; Sugars; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Carbohydrates; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: David Hui, MD/ Associate Professor, Palliative Care Medicine
• Organization: UT MD Anderson Cancer Center

dhui@mdanderson.org

(713) 792-6258

Study Officials

• David Hui, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2012
• First Posted: August 21, 2012
• Study Start: January 1, 2013
• Primary Completion: August 1, 2020
• Study Completion: January 26, 2021
• Last Updated: February 17, 2021
• Results First Posted: February 1, 2021

Record last verified: 2021-01

Locations

US (1)